Almac Pharma Services, part of the Almac Group, has completed three global regulatory GMP inspections across three facilities.
 
The UK MHRA conducted a routine GMP audit at the company’s Charnwood, UK facility.  The 230,000ft² site, based in Loughborough, was acquired by Almac in 2015 and provides GMP development and manufacturing of solid oral dose clinical trial materials and small scale commercial volumes. The three-day inspection of the site’s quality systems resulted in no critical or major findings.
 
Also, the company’s global HQ site in Craigavon, Northern Ireland received a general GMP inspection by the U.S. FDA. Operations at this site include GMP and non-GMP pharmaceutical development, commercial scale manufacturing and packaging of solid oral dose material, secondary labelling, serialisation and distribution of drug product globally. The inspection was also successful with no 483 issued.
 
The U.S. FDA also performed an inspection at the company’s Audubon, PA, facility which provides a range of specialised commercial packaging services including complex kit assembly for medical devices, combination products and biologic packs.  The inspection covered general aspects of GMP and the company’s operations with biologic products and, again, closed with no 483 being issued.
 
Ian Markwell vice president of Quality, responsible for the company’s global regulatory compliance, said, “It is unprecedented for the Almac Pharma Services business to have three regulatory authority inspections within such a short period of time.  It is a great credit to the skilled and experienced teams involved across all locations that they resulted in a positive outcome.”
 
Graeme McBurney, managing director and president, Almac Pharma Services said, “We recognize that quality determines the extent of our success and therefore place a high priority on ensuring our company-wide quality systems not only meet, but exceed, global regulatory standards. Successful completion of these inspections at our multiple global facilities reflects our ongoing commitment to quality and teamwork across the entire organization.”